FDA Medical Device Recalls (openFDA)
Bioteque America Inc: Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
- Recall number
- Z-0027-05
- Recalling firm
- Bioteque America Inc
- Product
- Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
- Status
- Terminated
- Initiated
- 2005-02-24
- Posted
- 2005-03-23
- Terminated
- 2005-06-14
- Reason
- product is marketed without a 510(k)
- Root cause
- Other
- Action
- The recalling firm telephoned the distributors and sales representatives on 2/23/05 informing them of the problem and the need to return the product. As a follow up to the telephone call, a recall letter dated 2/24/05 was issued to the distributors.
- Quantity
- 115 units
- Distribution
- The products were shipped to distributors in OH and MI. The product was also provided to sales representatives.
- Lot, serial or model codes
- Lot number 741105 exp 11/07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000121341
- Firm city
- Langhorne
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28